Country: Велика Британија
Језик: Енглески
Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)
Loperamide hydrochloride
Sigma Pharmaceuticals Plc
A07DA03
Loperamide hydrochloride
2mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01040200
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Loperamide 2 mg Capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 2mg loperamide hydrochloride. Excipient(s) with known effect: Each capsule contains 109.00 mg lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard (Capsule) Size '4' (about 14 mm in length) Hard gelatin capsule with Green cap imprinted with 'L' in black ink & grey body imprinted with '2mg' in black ink, containing white to off-white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic treatment of acute diarrhoea in adults and children aged 12 years and over. For the symptomatic treatment of acute episodes of diarrhoea associated with Irritable Bowel Syndrome in adults aged 18 years and over following initial diagnosis by a doctor. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY ACUTE DIARRHOEA Adults and children over 12: Two capsules (4 mg) initially, followed by one capsule (2 mg) after each loose stool. The usual dose is 3-4 capsules (6 mg – 8 mg) a day. The total daily dose should not exceed 6 capsules (12 mg). SYMPTOMATIC TREATMENT OF ACUTE EPISODES OF DIARRHOEA ASSOCIATED WITH IRRITABLE BOWEL SYNDROME IN ADULTS AGED 18 YEARS AND OVER Two capsules (4 mg) to be taken initially, followed by 1 capsule (2 mg) after every loose stool, or as previously advised by your doctor. The maximum daily dose should not exceed 6 capsules (12 mg). PAEDIATRIC POPULATION Loperamide 2 mg Capsules are contraindicated in children less than 12 years of age. USE IN ELDERLY No dose adjustment is required for the elderly. RENAL IMPAIRMENT No dose adjustment is required for patients with renal impairment. HEPATIC IMPAIRMENT Although no pharmacokinetic data are available in patients with hepatic impairment, Loperamide 2 mg Capsules should be used with caution in such patients because of reduced first pass metabolism (see 4.4 Special warnings and precautions for use). Method of administration Or Прочитајте комплетан документ